STUDY TO EVALUATE CORNEAL SURGERY FOR ASTIGMATISM
A group of 14 corneal specialists from the United States and Canada have begun a 1-year clinical study to determine the safety and effectiveness of arcuate keratotomy performed with a diamond knife.
The Astigmatism Reduction Clinical Trial (ARC-T) is the first multicenter study developed for analyzing the results of eyes that have undergone astigmatic keratotomy.
Participating surgeons began enrolling patients at their respective study sites in May and are looking to recruit more. The group hopes to enroll 200 initial patients.
The procedure will be performed using uniform arc-shaped corneal incisions, similar to those used in radial keratotomy. Data will be analyzed at a central study center and several scientific presentations will be given within the year following the conclusion of patient enrollment.
Patients will be grouped into three categories: naturally occurring astigmatism/regular corneal astigmatism, postcataract extraction regular astigmatism, and posttraumatic regular astigmatism. Postkeratoplasty astigmatism was excluded. However, the group is considering a second study to evaluate patients in this category.
A 1.00- to 6.00-diopter range of astigmatism will be evaluated. Patients may also have myopia, but combined surgery will not be performed to allow the response to astigmatism surgery to be evaluated. Any residual myopia will be treated with radial keratotomy or the excimer laser after the patients' corneas have stabilized.
Refractive, keratometry, and corneal topography measurements will be evaluated 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery.
The privately funded study has been in the planning stages for nearly 8 years. Originally, it was going to be called the prospective evaluation of astigmatic keratotomy or PEAK study, but the participants were unable to attain appropriate funding.
R. Bruce Grene, MD, Wichita, Kan is the primary investigator. Participating surgeons are: Perry S. Binder, MD, La Jolla, Calif; Bruce I. Bodner, MD, Norfolk, Va; Daniel S. Durrie, MD, Kansas City, Mo; Henry Gelender, MD, Dallas, Tex; Kenneth R. Kenyon, MD and David Miller, MD, Boston, Mass; Richard L. Lindstrom, MD, Minneapolis, Minn; Francis W. Price, Jr, MD, Indianapolis, Ind; R. Doyle Stulting, MD, PhD, Keith Thompson, MD, and George O. Waring III, MD, FACS, Atlanta, Ga; Thomas O. Wood, MD, Memphis, Tenn; and Ralph W. Zabel, MD, Ottawa, Canada.